ZD 1839 in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically or cytologically confirmed adenocarcinoma of the prostate
• PSA at least 20 ng/mL at study entry
• Must have documented evidence of disease progression, defined by 1 of the following conditions:
• * Rising PSA documented after discontinuation of peripheral antiandrogens
• * Minimum evidence of progression is a 25% increase in PSA over the reference value, provided that the increase is at least 5 ng/mL
• * Must have a first increase in PSA documented at least 1 week after the reference value and a second increase in PSA documented at least 1 week after the first increase
• * Progressive measurable disease during androgen ablative therapy (including medical or surgical castration)
• Castrate level (no greater than 50 ng/mL) of testosterone required if receiving medical androgen-ablative therapy at study entry
• Concurrent luteinizing hormone-releasing hormone agonist therapy required if receiving this medication at study entry
• PATIENT CHARACTERISTICS:
• Age:
• 16 and over
• Performance status:
• ECOG 0-1
• Life expectancy:
• Not specified
• Hematopoietic:
• Absolute granulocyte count at least 1,500/mm3
• Platelet count at least 100,000/mm3
• Hepatic:
• Bilirubin no greater than 2 times upper limit of normal (ULN)
• AST/ALT no greater than 2.5 times ULN (5 times ULN if documented liver metastases)
• Renal:
• Creatinine no greater than 2 times ULN
• Other:
• No other malignancy within the past 5 years
• No active uncontrolled bacterial, fungal, or viral infection
• No significant neurological disorder that would preclude informed consent
• No other serious illness or medical condition that would preclude study
• PRIOR CONCURRENT THERAPY:
• Biologic therapy:
• Concurrent epoetin alfa allowed
• Chemotherapy:
• No prior chemotherapy
• No concurrent cytotoxic therapy
• Endocrine therapy:
• See Disease Characteristics
• At least 4 weeks since prior peripheral antiandrogens (6 weeks for bicalutamide)
• Concurrent steroids allowed if on stable dose for at least 4 weeks before study and no dose increase planned
• Radiotherapy:
• At least 4 weeks since prior radiotherapy except low-dose, nonmyelosuppressive radiotherapy approved by the National Cancer Institute of Canada, Clinical Trials Group
• Surgery:
• See Disease Characteristics
• No concurrent ophthalmic surgery
• Other:
• No prior investigational agents
• No other concurrent investigational therapy
• No concurrent ketoconazole
• No concurrent high-dose narcotic therapy for pain (e.g., morphine equivalent dose more than 60 mg/day)
• Concurrent bisphosphonates allowed